Comparative cross-over study of sildenafil and apomorphine for treating erectile dysfunction
Abstract
OBJECTIVE: To compare the effectiveness, safety and tolerability of sildenafil and apomorphine in Brazilian patients with erectile dysfunction (ED) of various causes.
PATIENTS AND METHODS: In all, 108 patients (mean age 55 years, sd 11) and documented ED for > or =6 months were included in 12 centres in Brazil. The patients were initially followed for 2 weeks and then randomized to initial treatment with apomorphine or sildenafil, taken before sexual intercourse, no more than once a day. The initial dose (2 mg apomorphine and 50 mg sildenafil) could be adjusted (to 3 mg apomorphine, or to 25 or 100 mg for sildenafil) depending on the effectiveness and tolerability during the first 4 weeks of treatment. The patients were re-evaluated after 8 weeks on treatment and, after a wash-out period of 2 weeks (no treatment), received the other study drug (other than that received in the first phase), and then had the same procedures as in the first phase.
RESULTS: In all, 97 patients were evaluated for therapeutic effectiveness, the overall effectiveness being assessed using two questions; sildenafil had a significantly higher proportion of affirmative answers for both (P < 0.001). Likewise, the estimates for the mean (sd) proportion of successful sexual intercourse, of 83.3 (4.7)% vs 40.3 (4.7)% and the total ED Inventory of Treatment Satisfaction score, of 86.7 (2.9) vs 56.9 (2.9) (P < 0.001) were higher for sildenafil. At the end of the study, 93.8% of the patients randomized to…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 108 participants or records.
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